Study of Polmacoxib to Reduce Opioid Use and Manage Pain After Rotator Cuff Tear Surgery

What this Trial Is About

This research evaluates pain management methods in adults undergoing surgery for rotator cuff tears, focusing on reducing opioid use after surgery. The study compares the effects of Polmacoxib, taken once daily, combined with non-NSAID non-opioid or opioid analgesics, against analgesics alone. Participants must meet specific criteria including age and health status, with safety and treatment effects monitored throughout the study period. Participants are randomly assigned to one of two groups one receives Polmacoxib Acelex cap 2mg once daily plus pain medications as needed, and the other receives only non-NSAID non-opioid or opioid analgesics as needed. Medication administration starts two hours before surgery. Follow-up visits occur at three days, two weeks, six weeks, and three months post-surgery for data collection and monitoring. Throughout the study, participants will undergo evaluations including pain scoring, joint motion assessment, and questionnaires such as UCLA and ASES scores. Optional MRI scans are performed at 12 weeks to check for tendon re-tears. Researchers track analgesic use and any adverse events, with follow-up continuing until safety concerns stabilize or resolve. The study concludes after the three-month visit unless extended for safety monitoring.

Perioperative Polmacoxib Reduce Opioid Consumption for Post Operative Pain After Rotator Cuff Tear.